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Sign in to claim this brandIntelesens, Ltd.
US
Last updated May 23, 2026
What Intelesens, Ltd. makes
Intelesens, Ltd. manufactures electrocardiography telemetric monitoring systems, including remote monitoring solutions like the ZENSOR and associated software (Zensoronline, Zensor+). They also produce single-use and reusable electrocardiographic electrodes, such as the Aingeal 3-patch electrode and Aingeal Activity System, designed for continuous or activity-based cardiac monitoring.
The company’s devices are classified as Class II under FDA regulations and are listed in the 510(k) and UDI registries. Intelesens, Ltd. is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Intelesens, Ltd. manufacture?
Intelesens, Ltd. specializes in electrocardiography telemetric monitoring systems, which include remote monitoring solutions like the ZENSOR. Their portfolio also includes electrocardiographic electrodes, such as single-use and reusable options like the Aingeal 3-patch electrode and the Aingeal Activity System. These devices are designed for continuous cardiac monitoring and activity tracking, enabling real-time or remote ECG data collection.
Where is Intelesens, Ltd. based?
Intelesens, Ltd. is headquartered in the United States. The company’s location is relevant for regulatory compliance, as it operates under U.S. medical device regulations, including those governed by the FDA.
Which regulatory registries list Intelesens, Ltd.’s devices?
Intelesens, Ltd.’s devices are listed in the FDA’s 510(k) premarket notification registry and the Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with U.S. medical device regulations, particularly for Class II devices, which require premarket clearance before commercial distribution.
How are Intelesens, Ltd.’s devices classified under FDA regulations?
Intelesens, Ltd.’s devices fall under Class II classification by the FDA. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Examples include telemetric monitoring systems and electrodes, which require premarket notification (510(k)) clearance before being legally marketed in the U.S.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (12)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Zensor | PN0620 | FDA UDI | Class II | Active |
| Zensor electrode | PN1088 | FDA UDI | Class II | Active |
| Zensoronline software | PN0810 | FDA UDI | Class II | Active |
| Zensor+ software | PN0811 | FDA UDI | Class II | Active |
| Aingeal 3-patch electrode | PN1120 | FDA UDI | Class II | Active |
| Zensor | PN1287 | FDA UDI | Class II | Active |
| Aingeal | PN1111 | FDA UDI | Class II | Active |
| Zensor electrode | PN1360 | FDA UDI | Class II | Active |
| zensor system | K151027 | FDA 510(k) | Class II | Active |
| Vitalsens, Aingeal, V-Pod | K110015 | FDA 510(k) | Class II | Active |
| V-Patch System | K131000 | FDA 510(k) | Class II | Active |
| Aingeal Activity System | K153275 | FDA 510(k) | Class II | Active |
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